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510(k) K010981

GSA GENITO SENSORY ANALYZER by Medoc Ltd. Advanced Medical Systems — Product Code LLN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2001
Date Received
April 2, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vibration Threshold Measurement
Device Class
Class I
Regulation Number
882.1200
Review Panel
NE
Submission Type

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  • K910624 — CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 (January 17, 1992)
  • K872931 — TECA/MEDELEC TTT THERMAL THRESHOLD TESTER (November 16, 1987)
  • K863607 — VIBRATRON II, VIBRATION SENSITIVITY TESTER (December 3, 1986)